The 2b/3 did not do amyloid PET before AND after 48 week treatment. That is the recognized valid surrogate biomarker used by the MAbs. The 2b/3 does have CSF markers which would include AB42 and tau ( or pTau) and others. AB42 tau ratios correlate with PET. Anavex could argue they are valid biomarkers but we have not seen any actual data to determine how pure the association is and whether multiplicity would need to reduce the p threshold. Or if sequential analysis was in the SAP whether the statistical hierarchy realized valid by the time a significant to was reached. (Also what method of imputation was used for patients lacking the follow up CSF). I’ll stick to my 1000 shares for now awaiting Rett and continue to expect a completed significant phase three to be needed for AD NDA
At about 26:30 in your linked presentation the FDA slide mentions AA based on use of the product having either "a clinical endpoint that can be measured earlier than irreversible morbidity or mortality", or "an effect on a surrogate endpoint that is reasonably likely to predict an effect". The remainder of that presentation then focused on surrogates, as this was the data for that particular application. For A 2-73 there should be both clinical and surrogate data. This is why I am attaching importance to the level of "super response".
Having both clinical and surrogate data gives us more shots on goal...
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